Dr. Andrew Feilden
Director Analytical Science
Dr. Andrew Feilden joined Bicycle Therapeutics as CMC Director of Analytical Science, where he is responsible for regulatory testing.
He has previously held leadership positions at CROs specialising in extractable and leachable testing. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and technical thought leadership activities.
Andrew has presented on the field of extractables and leachables in over 17 countries worldwide. He has written a number of papers and publications and is the inventor of 2 patents.
He has a degree and D Phil from the university of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
DAY 2: MARCH 10th, 2023
SESSION: Extractables and leachables potential concerns with high potency APIs
◆ Why are large molecules of more concern.
◆ Challenges of highly hazardous APIs.
◆ Interaction of biologicals with leachables.
DAY 2: MARCH 31st, 2022
SESSION: Similarities and differences between medicinal products and medical devices for extractable and leachable testing
◆ What are medical devices.
◆ What are the key challanges achieving chemical characterisation.
◆ The role of uncertainty factors in determining levels.
DAY 1: MAY 19th, 2021
SESSION: Effective E&L study designs
◆ Key factors in designing extraction studies.
◆ Factors to consider when designing and implementing leachable studies.
